A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria.
研究概览
简要总结
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
详细描述
Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable.
Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Have documented or reported gross hematuria within 3 month of study enrollment
- •Willing and able to give written informed consent
排除标准
- •(patients must not):
- •Have history of BCa
- •History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years
- •Have a known active urinary tract infection or urinary retention
- •Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) Serum creatinine value can be up to 60 days before consent, otherwise repeat
- •Have ureteral stents, nephrostomy tubes or bowel interposition
- •Have recent genitourinary instrumentation (within 10 days prior to signing consent)
- •Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
结局指标
主要结局
To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria.
时间窗: 1 year
次要结局
- To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.(1 year)
- To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.(1 year)
研究者
Charles Rosser
Professor
Cedars-Sinai Medical Center